Use of the WALANT Anesthesia Technique for Forefoot Surgery.

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04858048
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 28.5
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

To compare the perioperative pain level with WALANT anesthesia versus general anesthesia during forefoot surgery.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder	Procedure: Anesthesia

Detailed Description

Orthopaedic foot and ankle surgery is typically performed while the patient is under general or regional anesthesia. The Wide Awake Local Anesthesia No Tourniquet (WALANT) technique is a local anesthesia technique used since 1980s in Canada for hand surgery. WALANT uses a combination of a local anesthetic and vasoconstrictor to induce anesthesia and hemostasis in the area of the surgical procedure in order to allow surgeries to be done without the use of tourniquet. This practice eliminates the need for the tourniquet due to the hemostatic effect of the vasoconstrictor. The administration of the local anesthetic is done as close as possible to the surgical site, which allows the mobility of the joint to be maintained, while having complete anesthesia. The retention of mobility and the absence of a tourniquet improve patient comfort.

The main objective of this prospective study is to evaluate the perioperative pain level with WALANT anesthesia compared to general anesthesia during forefoot surgery.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Use of the WALANT Anesthesia Technique for Forefoot Surgery.
• Actual Study Start Date: Jan 15, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group with general anesthesia performed during the forefoot surgery	Procedure: Anesthesia; 2 types of anesthesia (general and WALANT) performed during the surgery
Group with WALANT anesthesia performed during the forefoot surgery	Procedure: Anesthesia; 2 types of anesthesia (general and WALANT) performed during the surgery

Outcome Measures

Primary Outcome Measures

1. Pain assessment [Perioperative]

   Measure of the pain using the VAS pain scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient, male or female, over 18 years of age

• Patient with scheduled forefoot surgery

Exclusion Criteria:

• Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision

• Pregnant or breastfeeding woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé saint Martin	Caen		France	14050

Sponsors and Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

• Principal Investigator: François LAVIGNE, Hôpital Privé Saint Martin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GCS Ramsay Santé pour l'Enseignement et la Recherche
• ClinicalTrials.gov Identifier: NCT04858048
• Other Study ID Numbers: 2020-A02531-38
• First Posted: Apr 26, 2021
• Last Update Posted: Apr 26, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Musculoskeletal Diseases; Anesthetics

Study Results

No Results Posted as of Apr 26, 2021